Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Quality Specialist serves as a technical quality resource supporting product quality, process quality, compliance, and continuous improvement initiatives. This position partners closely with Manufacturing, Engineering, and Operations teams to drive quality performance, reduce defects, improve processes, and support customer satisfaction.

Responsibilities

• Support and maintain compliance with the Praxis Quality Management System (QMS).
• Lead or participate in root cause investigations, corrective actions, and preventive actions (CAPA).
• Support nonconformance reporting, containment activities, investigation documentation, and disposition processes.
• Analyze quality data, trends, scrap, rework, customer feedback, and process performance metrics.
• Support validation activities, including IQ/OQ/PQ protocols and report execution.
• Assist with First Article Inspection Reports, process qualifications, and production approvals.
• Participate in internal audits, supplier audits, and external customer or regulatory audits.
• Support risk management and quality planning activities.
• Collaborate with Engineering and Manufacturing teams to improve process capability and product quality.
• Review and approve quality records, Device History Records, inspection data, and supporting documentation.
• Support training efforts related to quality procedures, good documentation practices, and compliance requirements.
• Assist with calibration, metrology, and measurement system analysis activities, including Gage R&R studies.
• Develop and maintain quality metrics, dashboards, and reporting tools.
• Champion continuous improvement initiatives using Lean Manufacturing and problem-solving methodologies.
• Promote a culture of quality, accountability, safety, and continuous improvement consistent with Praxis Core Values.

Requirements

• Associate's or Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related field, or equivalent combination of education and experience.
• 3+ years of experience in a quality role within manufacturing, medical device, aerospace, or regulated industries.
• Experience within ISO 13485 and/or AS9100 environments.
• Experience with validation protocols and statistical analysis.
• Experience with nonconformance management, investigations, and corrective action processes.
• Strong analytical and problem-solving skills.
• Ability to interpret engineering drawings, specifications, and customer requirements.
• Proficiency with Microsoft Office including Excel.
• Strong technical writing and documentation skills.
• Excellent communication and collaboration skills.
• Working knowledge of risk management methodologies.
• Experience with electronic Quality Management Systems (eQMS).
• Lean Manufacturing, Six Sigma, or continuous improvement experience.
• ASQ Certified Quality Technician (CQT), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE).
• Experience supporting customer audits and regulatory inspections.
• Work is performed in both office and manufacturing environments.
• Ability to stand, walk, sit, and move throughout production areas.
• Occasional lifting of up to 50 pounds.
• Visual acuity sufficient for inspection, documentation review, and computer work.
• Frequent interaction with associates, leadership, suppliers, auditors, and customers.
• Moderate exposure to manufacturing equipment and production environments.

Skills

• ISO 13485
• AS9100
• Validation protocols
• Statistical analysis
• Nonconformance management
• Corrective action processes
• Analytical skills
• Problem-solving skills
• Engineering drawing interpretation
• Specification interpretation
• Customer requirement interpretation
• Microsoft Office
• Excel
• Technical writing
• Documentation skills
• Communication skills
• Collaboration skills
• Risk management methodologies
• Electronic Quality Management Systems (eQMS)
• Lean Manufacturing
• Six Sigma
• Continuous improvement
• ASQ Certified Quality Technician (CQT)
• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• Customer audit support
• Regulatory inspection support

Location

• Office and manufacturing environments

Work Type

• Full-time

Experience Level

• 3+ years of experience

Education Level

• Associate's degree
• Bachelor's degree
• Equivalent combination of education and experience

Benefits

• Employee and/or Employee + Child(ren) medical insurance for just $1/month
• Comprehensive Dental + Vision
• 401k Retirement Plan with up to 3% match
• Basic Life AD&D Insurance
• Employee Assistance Program
• Paid time off - 18 days first year (pro-rated)
• Paid holidays – 9 days
• Annual Performance Bonus Potential
• Profit Sharing Program
• Employee Profit Sharing
• Tuition Assistance

About the Company

• Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets.
• We create sustainable flexibility that delivers maximum impact to make people’s lives better.
• We value people that are highly motivated, self-starters, open to learning new things every day.
• We look for like-minded individuals who will embrace the five core values of Praxis: Team player, Driven to improve, Genuinely care, Dependable, Own.

Equal Opportunity

• Praxis is an equal opportunity employer.